Vaccine HER1 / VSSP for prostate cancer, head and neck carcinoma and advanced colon cancer . Phase I

Phase 1

• Conditions: hormonal castration-resistant prostate cancer, squamous cell carcinoma of the head and neck, and advanced colon cancer; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases; Digestive System Neoplasms; Gastrointestinal Neoplasms

• Registration Number: RPCEC00000258
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Compliance with one of the defined diagnostic criteria.
2. Availability of the blocks to evaluate the expression, by immunohistochemical techniques, of R-EGF and biomarkers (such as K-ras, N-ras, B-raf, HPV and p16).
3. Patient giving written informed consent to participation.
4. Age over 18 years.
5. General condition according to ECOG = 2.
6. Life expectancy of at least 6 months.
7. Functioning of organs and bone marrow defined by the following parameters: Hemoglobin (Hb) = 10 g / dl, Total white blood cell count = 3 x 109 / L, 100 Platelet count (CP) = 100 x 109 / L , total bilirubin = 2.5 times the upper normal institutional limit, creatinine within normal limits for each institution.

Exclusion Criteria

1. Patients of childbearing potential who are not using a suitable method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or surgical sterilization).
2. Pregnant or breastfeeding.
3. Positive serology known to HIV, hepatitis B or C.
4. Acute allergic states or history of severe allergic reactions.
5. Acute or chronic decompensated lung diseases that may interfere with the follow-up of the underlying disease.
6. Previous history of demyelinating or inflammatory diseases of the central nervous system (CNS) or peripheral (PNS).
7. Uncontrolled intercurrent diseases including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, Diabetes Mellitus, and psychiatric diseases involving the incompetence of the subject.
8. Cerebral metastasis.
9. Known hypersensitivity to any component of the formulation.
10. Patients who are receiving another product under investigation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with serious adverse events with causal relationship (EAS with definite / highly probable or probable causality with HER1 vaccine). Time of measurement: 0, 14, 28, 42, 56, 84 112, 140, 168, 196, 224, 252, 280, 308, 336, and 364 days